A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients
A Phase II, Randomized Trial of Amprenavir as Part of Dual Protease Inhibitor Regimens (Placebo-Controlled) in Combination With Abacavir, Efavirenz, and Adefovir Dipivoxil Versus Amprenavir Alone in HIV-Infected Subjects With Prior Exposure to Approved Protease Inhibitors and Loss of Virologic Suppression as Reflected by a Plasma HIV-1 RNA Concentration >= 1,000 Copies/ml
3 other identifiers
interventional
475
2 countries
45
Brief Summary
The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir. Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have current virologic failure (2 consecutive HIV blood levels above 1,000 copies/ml) while on PIs.
- Are over 13 years of age (consent of parent or guardian required if under 18).
- Agree to practice abstinence or use effective methods of birth control during the study and for 90 days after.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have hepatitis within 90 days prior to study entry.
- Have a history of a peripheral neuropathy within 60 days of study entry.
- Have an unexplained temperature for a 7-day period.
- Have chronic diarrhea within 30 days prior to study entry.
- Have cancer requiring chemotherapy.
- Received any therapy for infection or other illness within 30 days prior to study entry.
- Have received certain other medications.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr
Los Angeles, California, 900334508, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Willow Clinic
Menlo Park, California, 94025, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Howard Univ
Washington D.C., District of Columbia, 20059, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225, United States
Queens Med Ctr
Honolulu, Hawaii, 96816, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Tripler Army Med Ctr
Tripler AMC, Hawaii, 96859, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Chelsea Ctr
New York, New York, 10021, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, 15213, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
Univ of Washington
Seattle, Washington, 981224304, United States
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
Related Publications (5)
Pfister M, Labbe L, Hammer SM, Mellors J, Bennett KK, Rosenkranz S, Sheiner LB; Adult AIDS Clinical Trial Group Study 398. Population pharmacokinetics and pharmacodynamics of efavirenz, nelfinavir, and indinavir: Adult AIDS Clinical Trial Group Study 398. Antimicrob Agents Chemother. 2003 Jan;47(1):130-7. doi: 10.1128/AAC.47.1.130-137.2003.
PMID: 12499180BACKGROUNDPfister M, Labbe L, Lu JF, Hammer SM, Mellors J, Bennett KK, Rosenkranz S, Sheiner LB; AIDS Clinical Trial Group Protocol 398 Investigators. Effect of coadministration of nelfinavir, indinavir, and saquinavir on the pharmacokinetics of amprenavir. Clin Pharmacol Ther. 2002 Aug;72(2):133-41. doi: 10.1067/mcp.2002.126183.
PMID: 12189360BACKGROUNDHammer SM, Vaida F, Bennett KK, Holohan MK, Sheiner L, Eron JJ, Wheat LJ, Mitsuyasu RT, Gulick RM, Valentine FT, Aberg JA, Rogers MD, Karol CN, Saah AJ, Lewis RH, Bessen LJ, Brosgart C, DeGruttola V, Mellors JW; AIDS Clinical Trials Group 398 Study Team. Dual vs single protease inhibitor therapy following antiretroviral treatment failure: a randomized trial. JAMA. 2002 Jul 10;288(2):169-80. doi: 10.1001/jama.288.2.169.
PMID: 12095381BACKGROUNDSun J, Nagaraj HN, Reynolds NR. Discrete stochastic models for compliance analysis based on an AIDS Clinical Trial Group (ACTG) study. Biom J. 2007 Aug;49(5):731-41. doi: 10.1002/bimj.200610368.
PMID: 17726714RESULTGhosh P, Ghosh K, Tiwari RC. Joint modeling of longitudinal data and informative dropout time in the presence of multiple changepoints. Stat Med. 2011 Mar 15;30(6):611-26. doi: 10.1002/sim.4119. Epub 2010 Nov 30.
PMID: 21337357RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Scott Hammer
- STUDY CHAIR
John Mellors